RecallGuide.ca
    Medical devicesUpdated Jan 3, 2026PhilipsOfficial source

    Philips BiPAP and Humidifiers recall in Canada: Sterility issue

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    In plain language

    This recall involves several models of Philips BiPAP devices and humidifiers sold in Canada. They are being recalled because the recommended disinfection method was not adequately validated, leading to a sterility issue. Stop using the product and contact the manufacturer for more information.

    What to do

    • Stop using the product immediately.
    • Contact the manufacturer for additional information.

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    Affected products

    • BiPAP A40 Pro, CA

      Model: CAX3100S12

      Lot: All lots

    • BiPAP A40, Canada, Core Package

      Model: 1111174

      Lot: All lots

    • BiPAP A30 System - Ventilator & System One Aseries Heated Humidifier

      Model: 1111148

      Lot: All lots

    • BiPAP A40 EFL

      Model: INX3T

      Lot: All lots

    • System One Heated Humidifier

      Model: IN6T INX3T IN6TFLG IN6H INX3H IN6HFLG

      Lot: All lots

    • BiPAP A40 Pro, CA W/ Heated Tube Humidifier, CA

      Model: CAX3100T12

      Lot: All Lots

    • System One A-Series Heated Humidifier

      Model: 1111552 1077107 1111555

      Lot: All Lots

    Why this matters

    Sterility issue

    Do I have this product?

    This recall only applies to specific products. Follow the steps below to check.

    1. 1

      Check the product name

      Make sure your product name matches one of the affected products listed above.

    2. 2

      Check the lot number

      Lot numbers identify specific production batches.

      Affected lots: All Lots, All lots

    3. 3

      Check the model number

      Model numbers are typically on the product label or packaging.

      Affected models: 1111148, 1111174, 1111552 1077107 1111555, CAX3100S12, CAX3100T12, IN6T INX3T IN6TFLG IN6H INX3H IN6HFLG, INX3T

    If your product matches one or more of the details above, it may be affected by this recall.

    If your product does not match these details, it is not affected by this recall.

    When in doubt, always check the official notice.

    Want alerts if similar products are recalled in Canada?

    Frequently Asked Questions

    Why was this product recalled?

    Sterility issue

    What should consumers do?

    Stop using the product immediately. Contact the manufacturer for additional information.

    Where was the product sold?

    This product was sold in Canada. For specific retailers or distribution areas, please check the official recall notice linked on this page.

    Is there a health risk?

    Yes, there may be a health risk. Sterility issue

    When was this product recalled?

    This product was recalled on July 10, 2023.

    Is the Philips brand affected by this recall?

    Yes, Philips products are affected by this recall. This recall involves several models of Philips BiPAP devices and humidifiers sold in Canada. They are being recalled because the recommended disinfection method was not adequately validated, leading to a sterility issue. Stop using the product and contact the manufacturer for more information.